NCT00727584

Radiation Therapy in Treating Patients With Metastatic Spinal Cord Compression

SCORAD: A Randomised Feasibility Study of Single Fraction Radiotherapy Compared to Multi-fraction Radiotherapy in Patients With Metastatic Spinal Cord Compression

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Cancer Research UK · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known which radiation therapy regimen is more effective in treating metastatic spinal cord compression. PURPOSE: This randomized clinical trial is comparing two radiation therapy regimens to see how well they work in treating patients with metastatic spinal cord compression.

Detailed description

OBJECTIVES: * To examine whether a phase III randomized study comparing a single-fraction of radiotherapy with multi-fraction radiotherapy is acceptable to clinicians and to patients with metastatic spinal cord compression. * To determine the feasibility of conducting this study in the United Kingdom. OUTLINE: This is a multicenter study. Patients are stratified by treatment center and known prognostic factors (ambulatory status at diagnosis, primary tumor type, and extent of disease \[spinal metastases only vs spinal and non-bony metastases\]). Patients are randomized to 1 of 2 treatment arms. * Arm I (multi-fraction radiotherapy): Patients undergo 5 fractions of 20 Gy external-beam radiotherapy. * Arm II (single-fraction radiotherapy): Patients undergo 1 fraction of 8 Gy external beam radiotherapy. Patients undergo assessment of ambulatory status, quality of life, bladder and bowel function, and acute toxicity via self-reported questionnaires and telephone follow-ups at baseline and weeks 1, 4, 8, and 12.

Conditions

• Spinal Cord Compression
• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
RADIATION	radiation therapy	Patients undergo external beam radiotherapy

Timeline

• Start date: 2007-11-01
• Primary completion: 2009-02-01
• Completion: 2009-08-01
• First posted: 2008-08-04
• Last updated: 2013-08-26

Locations

4 sites across 1 country: United Kingdom